BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUNA G3 BPAP 25A

    MDR report key: 24781543 · Received April 3, 2026

    Report

    Report Number
    3009096682-2026-00004
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 3, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    UDI-DI
    06948538365649
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    3B MEDICAL, INC. DBA REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ALLEGING THAT THE LUNA G3 BPAP¿S WAS UNABLE TO MAINTAIN PRESSURE, WHICH COULD RESULT IN LOW PRESSURE DELIVERY, AND THE DEVICE¿S USAGE REPORT INDICATED ¿IRREGULARITIES.¿ ACCORDING TO THE DME, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ¿BREATHING ISSUES¿ FOLLOWING DEVICE USE. SHE HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS BACK AT HOME. THE PATIENT HAS DISCONTINUED USING THIS DEVICE AND ANOTHER WAS ISSUED FROM THE DME'S INVENTORY. NO FURTHER INFORMATION ABOUT THE PATIENT HAS BEEN PROVIDED. 3B MEDICAL, INC. CONTINUES TO INVESTIGATE THE REPORTED ISSUE. THE DEVICE HAS BEEN SENT TO THE MANUFACTURER, BMC MEDICAL CO., LTD (¿BMC¿), FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838640 LUNA G3 BPAP 25A VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD G3-B25A 06948538365649

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization